A federal court in the District of Columbia has determined that “the cultured cell product is a drug within the meaning of the Federal Food, Drug, and Cosmetic Act” and “a biological product within the meaning of 42 U.S.C. § 262,” and imposed a permanent injunction against a company and several individuals who allegedly manufactured and distributed misbranded and adulterated stem cells. United States v. Regenerative Sciences, LLC, No. 1:10-cv-01327-RMC (U.S. Dist. Ct., D.D.C., decided July 23, 2012). The U.S. Food and Drug Administration (FDA) had sought the injunction against Regenerative Sciences, “citing violations of current good manufacturing practice (CGMP) that cause its cultured cell product to be adulterated.” FDA also alleged that the product was “misbranded due to the lack of adequate directions for use and the failure to bear the ‘Rx only’ symbol.” See FDA News Release, August 6, 2010.
The cultured cell product at issue was “derived from a patient’s bone marrow or fluid surrounding the patient’s joints (synovial fluid). The cells are grown, processed, and mixed with drug products outside the body before being injected back into the patient.”
The court’s order gives FDA access to the defendants’ facilities without prior notice to monitor and ensure compliance and requires the defendants to reimburse FDA for the costs of all such inspections. The defendants are further required to hire an independent third party to inspect their facilities to “determine whether their methods, facilities, and controls are operated and administered in conformity with CGMP and to evaluate the labeling of Defendants’ cultured cell product and any other drugs manufactured, processed, packed, labeled, held, and distributed by Defendants to determine whether they are in compliance with 21 U.S.C. §§ 352(f) and 353(b)(4).” The order does not apply “to drugs that are both (A) the subject of an effective new drug application or biologics license application approved by FDA and (B) not manufactured, processed, packed, or labeled by Defendants.”